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Three Versus 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Patients With Stage III Colon Cancer: Disease-Free Survival Results From a Randomized, Open-Label, International Duration Evaluation of Adjuvant (IDEA) France, Phase III Trial

Thierry André 1, 2, 3 Dewi Vernerey 4, 5 Laurent Mineur 6 Jaafar Bennouna 7 Jérôme Desramé 8 Roger Faroux 9 Serge Fratte 4, 10 Marine Hug de Larauze 3 Sophie Paget-Bailly 4 Benoist Chibaudel 1, 3 Jérémie Bez 11 Jérôme Dauba 12 Christophe Louvet 13 Céline Lepère 14 Olivier Dupuis 15 Yves Bécouarn 16 May Mabro 17 J. Egreteau 18 Olivier Bouché 19 Gaël Deplanque 20 Marc Ychou 21, 22 Marie-Pierre Galais 23 François Ghiringhelli 24 Louis Marie Dourthe 25 Jean-Baptiste Bachet 26, 2 Ahmed Khalil 27 Franck Bonnetain 5 Aimery de Gramont 28 Julien Taieb 14, 29, 30
Abstract : Purpose : Reduction of adjuvant treatment duration may decrease toxicities without loss of efficacy in stage III colon cancer. This could offer clear advantages to patients and health care providers. Methods : In International Duration Evaluation of Adjuvant Chemotherapy (IDEA) France, as part of the IDEA international collaboration, patient with colon cancer patients were randomly assigned to 3 and 6 months of modified FOLFOX6 (mFOLFOX6: infusional fluorouracil, leucovorin, and oxaliplatin) or capecitabine plus oxaliplatin (CAPOX) by physician choice. The primary end point was disease-free survival (DFS), and analyses were descriptive. Results : A total of 2,010 eligible patients received either 3 or 6 months of chemotherapy (modified intention-to-treat population); 2,000 (99%) had stage III colon cancer (N1: 75%, N2: 25%); 1,809 (90%) received mFOLFOX6, and 201 (10%) received CAPOX. The median age was 64 years, and the median follow-up time was 4.3 years. Overall, 94% (3 months) and 78% (6 months) of patients completed treatment (fluoropyrimidines ± oxaliplatin). Maximal grade 2 and 3 neuropathy rates were 28% and 8% in the 3-month arm and 41% and 25% in the 6-month arm ( P < .001). Final rates of residual neuropathy greater than grade 1 were 3% in the 3-month arm and 7% in the 6-month arm ( P < .001). There were 578 DFS events: 314 and 264 in the 3- and 6-month arms, respectively. The 3-year DFS rates were 72% and 76% in the 3- and 6-month arms, respectively (hazard ratio [HR], 1.24; 95% CI, 1.05 to 1.46; P = .0112). In the 3 and 6-month arms, respectively, for patients who received mFOLFOX6, the 3-year DFS rates were 72% and 76% (HR, 1.27; 95% CI, 1.07 to 1.51); for the T4 and/or N2 population, they were 58% and 66% (HR, 1.44; 95% CI, 1.14 to 1.82); and for the T1-3N1 population, they were 81% and 83% (HR, 1.15; 95% CI, 0.89 to 1.49). Conclusion : IDEA France, in which 90% of patients received mFOLFOX6, shows superiority of 6 months of adjuvant chemotherapy compared with 3 months, especially in the T4 and/or N2 subgroups. These results should be considered alongside the international IDEA collaboration data.
Keywords : Oncology
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https://hal-univ-bourgogne.archives-ouvertes.fr/hal-01951156
Contributeur : Lnc - Université de Bourgogne <>
Soumis le : mardi 11 décembre 2018 - 11:45:48
Dernière modification le : mardi 27 octobre 2020 - 14:35:52

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Thierry André, Dewi Vernerey, Laurent Mineur, Jaafar Bennouna, Jérôme Desramé, et al.. Three Versus 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Patients With Stage III Colon Cancer: Disease-Free Survival Results From a Randomized, Open-Label, International Duration Evaluation of Adjuvant (IDEA) France, Phase III Trial. Journal of Clinical Oncology, American Society of Clinical Oncology, 2018, 36 (15), pp.1469-1477. ⟨10.1200/JCO.2017.76.0355⟩. ⟨hal-01951156⟩

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